The following data is part of a premarket notification filed by Gynescope Corp. with the FDA for Wallace Intrauterine Insemination Catheter.
| Device ID | K901530 |
| 510k Number | K901530 |
| Device Name: | WALLACE INTRAUTERINE INSEMINATION CATHETER |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Kip Marlow |
| Correspondent | Kip Marlow GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-02 |
| Decision Date | 1990-07-23 |